Brand Name | TORNIER SIMPLICITI NUCLEUS SIZE 1 |
Type of Device | PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM |
Manufacturer (Section D) |
TORNIER INC |
10801 nesbitt avenue s |
bloomington MN 55437 |
|
Manufacturer (Section G) |
TORNIER INC |
10801 nesbitt avenue s |
|
bloomington MN 55437 |
|
Manufacturer Contact |
anna
jusinski
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 18381545 |
MDR Text Key | 331180208 |
Report Number | 0001649390-2023-00358 |
Device Sequence Number | 1 |
Product Code |
PKC
|
UDI-Device Identifier | 00846832091874 |
UDI-Public | 00846832091874 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K143552 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Study |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/21/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Catalogue Number | DWG401 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
05/06/2022
|
Initial Date FDA Received | 12/22/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 69 YR |
Patient Sex | Female |
Patient Weight | 95 KG |